Why it was recalled
Presence of particulate matter: glass
Product description
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Lot numbers, UPCs & expiration codes
Lot #: BL12206A, Exp date 06/30/2024
Where it was sold
Nationwide in the USA, Netherlands and Libya
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0261-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Dec 21, 2023
- FDA report date
- Jan 31, 2024
- Quantity
- 3,546 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PFIZER
Original FDA data
Every field from FDA enforcement report D-0261-2024, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 93693
- Address
- 66 Hudson St
- Code information
- Lot #: BL12206A, Exp date 06/30/2024
- Postal code
- 10013
- Report date
- Jan 31, 2024
- Product type
- Drugs
- Recall number
- D-0261-2024
- Classification
- Class I
- Recalling firm
- PFIZER
- Product quantity
- 3,546 vials
- Reason for recall
- Presence of particulate matter: glass
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
- Distribution pattern
- Nationwide in the USA, Netherlands and Libya
- Recall initiation date
- Dec 21, 2023
- Initial firm notification
- Press Release
- Center classification date
- Jan 25, 2024